ID

39769

Descripción

Axitinib as Second-line Treatment for Advanced Hepatocellular Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT01273662

Link

https://clinicaltrials.gov/show/NCT01273662

Palabras clave

Versiones (2)
  1. 18/2/20 18/2/20 -
  2. 27/9/21 27/9/21 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

18 de febrero de 2020

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Hepatocellular Carcinoma NCT01273662

Inglés

Eligibility Hepatocellular Carcinoma NCT01273662

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically diagnosed hcc, or clinically diagnosed hcc
Descripción

Liver carcinoma

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2239176
inoperable tumor(s) and no applicable curative therapy. not amenable to loco-regional therapy
Descripción

Tumor Inoperable | Curative treatment Unsuccessful | Tumor Inappropriate Therapy Local-Regional

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0027651
UMLS CUI [1,2]
C0205187
UMLS CUI [2,1]
C1273390
UMLS CUI [2,2]
C1272705
UMLS CUI [3,1]
C0027651
UMLS CUI [3,2]
C1548788
UMLS CUI [3,3]
C0087111
UMLS CUI [3,4]
C1947913
documented progression with or intolerance to sorafenib treatment as first- line therapy for advanced hcc
Descripción

sorafenib | Disease Progression | Intolerance to Sorafenib | First line treatment Liver carcinoma Advanced

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1516119
UMLS CUI [2]
C0242656
UMLS CUI [3,1]
C1744706
UMLS CUI [3,2]
C1516119
UMLS CUI [4,1]
C1708063
UMLS CUI [4,2]
C2239176
UMLS CUI [4,3]
C0205179
at least one measurable tumor, according to recist version 1.1, that has not been treated with any local procedure
Descripción

Measurable Disease Quantity | Local Therapy Absent

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C1265611
UMLS CUI [2,1]
C1517925
UMLS CUI [2,2]
C0332197
ecog performance status 0 or 1
Descripción

ECOG performance status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1520224
life expectancy is at least 2 months
Descripción

Life Expectancy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0023671
child-pugh class a liver function.
Descripción

Liver function Child-Pugh Classification

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0232741
UMLS CUI [1,2]
C2347612
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
systemic therapy other than sorafenib as first-line therapy for advanced hcc
Descripción

Systemic therapy Except Sorafenib | First line treatment Liver carcinoma Advanced

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1515119
UMLS CUI [1,2]
C0332300
UMLS CUI [1,3]
C1516119
UMLS CUI [2,1]
C1708063
UMLS CUI [2,2]
C2239176
UMLS CUI [2,3]
C0205179
history of hcc tumor rupture
Descripción

Liver carcinoma Tumour rupture

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2239176
UMLS CUI [1,2]
C2938957
presence of brain or leptomeningeal metastases
Descripción

Metastatic malignant neoplasm to brain | Metastatic Malignant Neoplasm to the Leptomeninges

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0220650
UMLS CUI [2]
C1704231
esophageal/gastric varices or active peptic ulcers that are considered to have high risk of bleeding
Descripción

Esophageal Varices | Gastric Varices | Peptic Ulcer | High risk of bleeding

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0014867
UMLS CUI [2]
C0017145
UMLS CUI [3]
C0030920
UMLS CUI [4]
C4039184
history of upper gastrointestinal bleeding within 1 year
Descripción

Upper gastrointestinal hemorrhage

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0041909
major systemic diseases that the investigator considers inappropriate for participation
Descripción

Systemic disease Major | Study Subject Participation Status Inappropriate

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0442893
UMLS CUI [1,2]
C0205164
UMLS CUI [2,1]
C2348568
UMLS CUI [2,2]
C1548788
uncontrollable hypertension
Descripción

Uncontrolled hypertension

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1868885
proteinuria
Descripción

Proteinuria

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0033687
current use or anticipated need for treatment with potent cyp3a4 inhibitor, cyp3a4 or cyp1a2 inducers
Descripción

CYP3A4 Inhibitor Strong | CYP3A4 Inducers Strong | CYP1A2 Inducers Strong | Patient need for CYP3A4 Inhibitor Strong | Patient need for CYP3A4 Inducers Strong | Patient need for CYP1A2 Inducers Strong

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3830624
UMLS CUI [1,2]
C0442821
UMLS CUI [2,1]
C3850041
UMLS CUI [2,2]
C0442821
UMLS CUI [3,1]
C3850050
UMLS CUI [3,2]
C0442821
UMLS CUI [4,1]
C0686904
UMLS CUI [4,2]
C3830624
UMLS CUI [4,3]
C0442821
UMLS CUI [5,1]
C0686904
UMLS CUI [5,2]
C3850041
UMLS CUI [5,3]
C0442821
UMLS CUI [6,1]
C0686904
UMLS CUI [6,2]
C3850050
UMLS CUI [6,3]
C0442821
requirement of anticoagulant therapy with oral vitamin k antagonists
Descripción

Requirement Anticoagulant therapy | Requirement Vitamin K antagonists Oral

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1514873
UMLS CUI [1,2]
C0150457
UMLS CUI [2,1]
C1514873
UMLS CUI [2,2]
C3653316
UMLS CUI [2,3]
C1527415
dementia or significantly altered mental status that would prohibit the understanding or rendering of informed consent and compliance with the requirements of this protocol
Descripción

Dementia Preventing Informed Consent | Altered mental state Preventing Informed Consent | Dementia Preventing Protocol Compliance | Altered mental state Preventing Protocol Compliance

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0497327
UMLS CUI [1,2]
C1292733
UMLS CUI [1,3]
C0021430
UMLS CUI [2,1]
C0278061
UMLS CUI [2,2]
C1292733
UMLS CUI [2,3]
C0021430
UMLS CUI [3,1]
C0497327
UMLS CUI [3,2]
C1292733
UMLS CUI [3,3]
C0525058
UMLS CUI [4,1]
C0278061
UMLS CUI [4,2]
C1292733
UMLS CUI [4,3]
C0525058
other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation and in the judgment of the investigator would make the patient inappropriate for entry into this study
Descripción

Medical condition Study Subject Participation Status At risk | Chronic disease Study Subject Participation Status At risk | Mental disorders Study Subject Participation Status At risk | Chronic mental disorder Study Subject Participation Status At risk | Laboratory test result abnormal Study Subject Participation Status At risk | Medical condition Study Subject Participation Status Inappropriate | Chronic disease Study Subject Participation Status Inappropriate | Mental disorders Study Subject Participation Status Inappropriate | Chronic mental disorder Study Subject Participation Status Inappropriate | Laboratory test result abnormal Study Subject Participation Status Inappropriate

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C1444641
UMLS CUI [2,1]
C0008679
UMLS CUI [2,2]
C2348568
UMLS CUI [2,3]
C1444641
UMLS CUI [3,1]
C0004936
UMLS CUI [3,2]
C2348568
UMLS CUI [3,3]
C1444641
UMLS CUI [4,1]
C0870281
UMLS CUI [4,2]
C2348568
UMLS CUI [4,3]
C1444641
UMLS CUI [5,1]
C0438215
UMLS CUI [5,2]
C2348568
UMLS CUI [5,3]
C1444641
UMLS CUI [6,1]
C3843040
UMLS CUI [6,2]
C2348568
UMLS CUI [6,3]
C1548788
UMLS CUI [7,1]
C0008679
UMLS CUI [7,2]
C2348568
UMLS CUI [7,3]
C1548788
UMLS CUI [8,1]
C0004936
UMLS CUI [8,2]
C2348568
UMLS CUI [8,3]
C1548788
UMLS CUI [9,1]
C0870281
UMLS CUI [9,2]
C2348568
UMLS CUI [9,3]
C1548788
UMLS CUI [10,1]
C0438215
UMLS CUI [10,2]
C2348568
UMLS CUI [10,3]
C1548788
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Similar models

Eligibility Hepatocellular Carcinoma NCT01273662

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Liver carcinoma
Item
histologically diagnosed hcc, or clinically diagnosed hcc
boolean
C2239176 (UMLS CUI [1])
Tumor Inoperable | Curative treatment Unsuccessful | Tumor Inappropriate Therapy Local-Regional
Item
inoperable tumor(s) and no applicable curative therapy. not amenable to loco-regional therapy
boolean
C0027651 (UMLS CUI [1,1])
C0205187 (UMLS CUI [1,2])
C1273390 (UMLS CUI [2,1])
C1272705 (UMLS CUI [2,2])
C0027651 (UMLS CUI [3,1])
C1548788 (UMLS CUI [3,2])
C0087111 (UMLS CUI [3,3])
C1947913 (UMLS CUI [3,4])
sorafenib | Disease Progression | Intolerance to Sorafenib | First line treatment Liver carcinoma Advanced
Item
documented progression with or intolerance to sorafenib treatment as first- line therapy for advanced hcc
boolean
C1516119 (UMLS CUI [1])
C0242656 (UMLS CUI [2])
C1744706 (UMLS CUI [3,1])
C1516119 (UMLS CUI [3,2])
C1708063 (UMLS CUI [4,1])
C2239176 (UMLS CUI [4,2])
C0205179 (UMLS CUI [4,3])
Measurable Disease Quantity | Local Therapy Absent
Item
at least one measurable tumor, according to recist version 1.1, that has not been treated with any local procedure
boolean
C1513041 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C1517925 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
ECOG performance status
Item
ecog performance status 0 or 1
boolean
C1520224 (UMLS CUI [1])
Life Expectancy
Item
life expectancy is at least 2 months
boolean
C0023671 (UMLS CUI [1])
Liver function Child-Pugh Classification
Item
child-pugh class a liver function.
boolean
C0232741 (UMLS CUI [1,1])
C2347612 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Systemic therapy Except Sorafenib | First line treatment Liver carcinoma Advanced
Item
systemic therapy other than sorafenib as first-line therapy for advanced hcc
boolean
C1515119 (UMLS CUI [1,1])
C0332300 (UMLS CUI [1,2])
C1516119 (UMLS CUI [1,3])
C1708063 (UMLS CUI [2,1])
C2239176 (UMLS CUI [2,2])
C0205179 (UMLS CUI [2,3])
Liver carcinoma Tumour rupture
Item
history of hcc tumor rupture
boolean
C2239176 (UMLS CUI [1,1])
C2938957 (UMLS CUI [1,2])
Metastatic malignant neoplasm to brain | Metastatic Malignant Neoplasm to the Leptomeninges
Item
presence of brain or leptomeningeal metastases
boolean
C0220650 (UMLS CUI [1])
C1704231 (UMLS CUI [2])
Esophageal Varices | Gastric Varices | Peptic Ulcer | High risk of bleeding
Item
esophageal/gastric varices or active peptic ulcers that are considered to have high risk of bleeding
boolean
C0014867 (UMLS CUI [1])
C0017145 (UMLS CUI [2])
C0030920 (UMLS CUI [3])
C4039184 (UMLS CUI [4])
Upper gastrointestinal hemorrhage
Item
history of upper gastrointestinal bleeding within 1 year
boolean
C0041909 (UMLS CUI [1])
Systemic disease Major | Study Subject Participation Status Inappropriate
Item
major systemic diseases that the investigator considers inappropriate for participation
boolean
C0442893 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
C2348568 (UMLS CUI [2,1])
C1548788 (UMLS CUI [2,2])
Uncontrolled hypertension
Item
uncontrollable hypertension
boolean
C1868885 (UMLS CUI [1])
Proteinuria
Item
proteinuria
boolean
C0033687 (UMLS CUI [1])
CYP3A4 Inhibitor Strong | CYP3A4 Inducers Strong | CYP1A2 Inducers Strong | Patient need for CYP3A4 Inhibitor Strong | Patient need for CYP3A4 Inducers Strong | Patient need for CYP1A2 Inducers Strong
Item
current use or anticipated need for treatment with potent cyp3a4 inhibitor, cyp3a4 or cyp1a2 inducers
boolean
C3830624 (UMLS CUI [1,1])
C0442821 (UMLS CUI [1,2])
C3850041 (UMLS CUI [2,1])
C0442821 (UMLS CUI [2,2])
C3850050 (UMLS CUI [3,1])
C0442821 (UMLS CUI [3,2])
C0686904 (UMLS CUI [4,1])
C3830624 (UMLS CUI [4,2])
C0442821 (UMLS CUI [4,3])
C0686904 (UMLS CUI [5,1])
C3850041 (UMLS CUI [5,2])
C0442821 (UMLS CUI [5,3])
C0686904 (UMLS CUI [6,1])
C3850050 (UMLS CUI [6,2])
C0442821 (UMLS CUI [6,3])
Requirement Anticoagulant therapy | Requirement Vitamin K antagonists Oral
Item
requirement of anticoagulant therapy with oral vitamin k antagonists
boolean
C1514873 (UMLS CUI [1,1])
C0150457 (UMLS CUI [1,2])
C1514873 (UMLS CUI [2,1])
C3653316 (UMLS CUI [2,2])
C1527415 (UMLS CUI [2,3])
Dementia Preventing Informed Consent | Altered mental state Preventing Informed Consent | Dementia Preventing Protocol Compliance | Altered mental state Preventing Protocol Compliance
Item
dementia or significantly altered mental status that would prohibit the understanding or rendering of informed consent and compliance with the requirements of this protocol
boolean
C0497327 (UMLS CUI [1,1])
C1292733 (UMLS CUI [1,2])
C0021430 (UMLS CUI [1,3])
C0278061 (UMLS CUI [2,1])
C1292733 (UMLS CUI [2,2])
C0021430 (UMLS CUI [2,3])
C0497327 (UMLS CUI [3,1])
C1292733 (UMLS CUI [3,2])
C0525058 (UMLS CUI [3,3])
C0278061 (UMLS CUI [4,1])
C1292733 (UMLS CUI [4,2])
C0525058 (UMLS CUI [4,3])
Medical condition Study Subject Participation Status At risk | Chronic disease Study Subject Participation Status At risk | Mental disorders Study Subject Participation Status At risk | Chronic mental disorder Study Subject Participation Status At risk | Laboratory test result abnormal Study Subject Participation Status At risk | Medical condition Study Subject Participation Status Inappropriate | Chronic disease Study Subject Participation Status Inappropriate | Mental disorders Study Subject Participation Status Inappropriate | Chronic mental disorder Study Subject Participation Status Inappropriate | Laboratory test result abnormal Study Subject Participation Status Inappropriate
Item
other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation and in the judgment of the investigator would make the patient inappropriate for entry into this study
boolean
C3843040 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C1444641 (UMLS CUI [1,3])
C0008679 (UMLS CUI [2,1])
C2348568 (UMLS CUI [2,2])
C1444641 (UMLS CUI [2,3])
C0004936 (UMLS CUI [3,1])
C2348568 (UMLS CUI [3,2])
C1444641 (UMLS CUI [3,3])
C0870281 (UMLS CUI [4,1])
C2348568 (UMLS CUI [4,2])
C1444641 (UMLS CUI [4,3])
C0438215 (UMLS CUI [5,1])
C2348568 (UMLS CUI [5,2])
C1444641 (UMLS CUI [5,3])
C3843040 (UMLS CUI [6,1])
C2348568 (UMLS CUI [6,2])
C1548788 (UMLS CUI [6,3])
C0008679 (UMLS CUI [7,1])
C2348568 (UMLS CUI [7,2])
C1548788 (UMLS CUI [7,3])
C0004936 (UMLS CUI [8,1])
C2348568 (UMLS CUI [8,2])
C1548788 (UMLS CUI [8,3])
C0870281 (UMLS CUI [9,1])
C2348568 (UMLS CUI [9,2])
C1548788 (UMLS CUI [9,3])
C0438215 (UMLS CUI [10,1])
C2348568 (UMLS CUI [10,2])
C1548788 (UMLS CUI [10,3])
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